Cleared Special

K063546 - INSUFLOW DEVICE, MODEL 6198

K063546 is an FDA 510(k) clearance for INSUFLOW DEVICE, manufactured by Lexion Medical, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Special 510(k) pathway after a 47-day FDA review.

K063546 · Lexion Medical, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
47d
Days
Class 2
Risk

K063546 is an FDA 510(k) clearance for the INSUFLOW DEVICE, MODEL 6198. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Lexion Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on January 10, 2007 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K063546

510(k) Number K063546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2006
Decision Date January 10, 2007
Days to Decision 47 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 161d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K063546.
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
K070783 · Sopro · Dec 2007
ARAGON SURGICAL LAPCAP
K070651 · Aragon Surgical, Inc. · May 2007
45L CORE INSUFFLATOR, MODEL F114
K063367 · W.O.M. World of Medicine AG · May 2007
VERESURE BELL
K061387 · Veresure, Inc. · Jul 2006
40 L HIGH FLOW INSUFFLATOR F113
K060723 · W.O.M. World of Medicine AG · May 2006
CARBONAID GAS DIFFUSER
K052125 · Cardia Innovation AB · Feb 2006
K063546 · INSUFLOW DEVICE, MODEL 6198
Download PDF FDA Summary Lexion Medical, LLC